Tagged Articles

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Many more revision surgeries occur in patients with all-metal hip implants

Nearly 75 percent of revision surgeries to remove and replace a hip replacement within five years of initial implantation occur in patients who received a metal-on-metal device, according to a Canadian study. Researchers pored through data involving 60,000 hip replacements performed across Canada between 2003 and 2011. They found that the need for revision surgery was greater in patients who had large-diameter modular metal-on-metal implants compared to patients who had more common plastic devices. Traditional hip replacement systems are made with ceramic or plastic parts, and can last 20 years or more before needing to be replaced. In the past ... Read More

Artery graft for aneurysm repair recalled due to potentially deadly defect

Several models of Albograft Vascular Grafts used to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or blockage (occlusion) caused by disease are being recalled because of a potentially deadly defect that can allow blood to leak from the surface of the graft after implantation. LeMaitre Vascular, Inc., ordered the recall on several models, which were distributed in Pennsylvania from April 2011 through June 2013. The recall is categorized as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will ... Read More

Corroding metal on artificial hip caused patient neurological symptoms

When orthopedic surgeon Stephen Tower realized in 2006 that in order to continue his recreational cycling he needed hip replacement surgery, he picked the newest and seemingly most durable hip implant on the market at the time – a metal-on-metal device made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. The hip implant was specifically marketed to younger, active patients like Stephen. However, after a year Stephen was having pain in his hip and balance issues that caused him to crash his bike. Within the next year, he began experiencing more problems – ringing in his ears, sleep apnea, ... Read More

FDA approves new silicone breast implant

Johnson & Johnson subsidiary Mentor has won Food and Drug Administration (FDA) approval to market a next-generation silicone breast implant. The MemoryShape breast implant uses a cross-linking gel that is designed to be firmer than previous implants. It is approved for women age 22 years or older. Silicone implants have traveled a rocky road in the medical device industry. In 2006, the FDA approved the first silicone breast implants – made by Mentor and Allergan – since banning silicone implants nearly 20 years earlier due to concerns that they caused illnesses in women who had them. That implant was approved ... Read More

British MPs call for criminal inquiry into toxic DePuy hip implants

British MPs have called for an investigation into DePuy Orthopaedics after testimony from a U.S. court case revealed that the medical device company continued to sell defective artificial hip implants despite knowing for at least three years they were toxic to patients. DePuy, a subsidiary of Johnson & Johnson, recalled the ASR hip replacement system and hip resurfacing system after mounting reports that the device was failing at a higher than expected rate. The recall affected an estimated 93,000 people worldwide. The DePuy device was made to be more durable with all-metal parts, as opposed to plastic or ceramic parts ... Read More

Hip implant failures more likely in women than men

Women are more likely to need revision surgery to remove and replace their artificial hips than men, according to a study published in JAMA Internal Medicine. The study, funded by the Food and Drug Administration (FDA) focused on the high number of failure rates in hip replacement systems. Researchers found that regardless of the type of hip implant used, hip replacements in women were more than 30 times more likely to fail than those implanted in men. Research involved more than 35,000 people who received hip replacement surgeries from one of 46 different hospitals in the Kaiser Permanente health system. ... Read More

New consortium aims to improve safety of medical devices

The Food and Drug Administration (FDA) has caught much flack in the past couple years over its medical device approval process, with critics arguing that not enough effort is made to ensure the safety and efficacy of devices before they hit the market. In response, a new consortium of leaders from industry, academia and government agencies was formed to help guide the advancement of medical device regulatory science. The Medical Device Innovation Consortium (MDIC), is a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). FDA Commissioner Dr. Margaret Hamburg called the formation of the consortium a ... Read More

International safety alert issued on metal hip device

Medsafe, New Zealand Medicines and Medical Devices Safety Authority, has issued an international safety alert on the Durom Acetabular Cup, an artificial hip device that was discontinued by its manufacturer in June 2011. The device has been failing at a higher than expected rate, causing some patients to undergo revision surgery to have their defective hip implants removed and replaced. The Durom Acetabular Cup, made by Zimmer Inc., is designed with metal-on-metal parts, just like the DePuy Orthopaedics ASR XL Acetabular hip replacement system and resurfacing system. The Depuy device was recalled by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, ... Read More

FDA advisory panel to review safety of all-metal hip implants

The safety of metal-on-metal hip implants will come under review by a Food and Drug Administration (FDA) advisory panel this week. The all-metal artificial hips made by companies such as Johnson & Johnson and Zimmer Holdings have been the source of numerous lawsuits by patients who claim the devices were defective and caused them injury. The metal devices have been associated with nearly 16,800 adverse events in the United States from 2000-2011. Artificial hips are typically made with ceramic or plastic parts, but last decade manufacturers began making the devices with all metal parts. It was thought that the devices ... Read More

Johnson and Johnson completes merger with troubled artificial hip maker

Johnson & Johnson has completed its acquisition of Synthes, Inc. and will integrate Synthes with its subsidiary DePuy Orthopaedics to establish the DePuy Synthes Companies of Johnson & Johnson. The deal was sealed with $19.7 billion in cash and stock. “The completion of the Synthes acquisition creates the world’s most innovative and comprehensive orthopaedics business and reflects our long-standing strategy of leadership within attractive health care markets,” said Alex Gorsky, Chief Executive Officer, Johnson & Johnson. “The combination of these two respected leaders — Synthes and DePuy — will enable us to better serve clinicians and patients worldwide, bring new ... Read More